FDA Registration Active 🇺🇸 United States

Vessel Shunt, 1.25mm Tip,12mm Shaft

Reg #: 1649139 · FEI: 3002406063 · Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1

Registration Details

Registration Name
KDL MEDICAL, INC.
Registration Number
1649139
FEI Number
3002406063
Status
Active
Expiry Year
2025
Initial Importer
No
Address
800 E Campbell Rd Ste 252
City
RICHARDSON
State
TX
ZIP
75081
Country
US

Regulatory Submissions

510(k) Number
K972665

Owner / Operator

Firm Name
KDL MEDICAL, INC. dba CHASE MEDICAL
Operator Number
9028011
Address
800 E. Campbell Rd., Suite 252
City
Richardson
State
TX
Postal Code
75081
Country
US
Correspondent
JACKIE LAFOLLETTE

Products

Device Name Product Code
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

Proprietary Names

Vessel Shunt, 1.25mm Tip,12mm Shaft Vessel Shunt, 2.5mm Tip,12mm Shaft Vessel Shunt, 3mm Plug, 30mm Shaft Vessel Shunt, 1.5mm Tip,12mm Shaft Vessel Shunt, 3mm Plug,12mm Shaft Vessel Shunt, 1.75mm Tip,12mm Shaft Vessel Shunt, 10mm Tip,12mm Shaft Vessel Shunt, 2mm Plug, 30mm Shaft Vessel Shunt, 2.5mm Plug, 30mm Shaft Vessel Shunt, 4mm Plug, 30mm Shaft Vessel Shunt, 2mm Tip,12mm Shaft Vessel Shunt, 4mm Plug,12mm Shaft Vessel Shunt, 2.25mm Tip, 12mm Shaft

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198